DCGI approved Itolizumab to treat COVID-19 patients with moderate to severe acute respiratory distress
India’s drug regulator has approved Itolizumab, a drug used to cure skin ailment psoriasis for “restricted emergency use” to treat COVID-19 patients... Read More
Bausch + Lomb – Stada Arzneimittel – Xbrane Biopharma – licensing deal for Lucentis biosimilar
Bausch + Lomb announced an exclusive licensing agreement with Stada Arzneimittel and its development partner Xbrane Biopharma to develop and commercialize a... Read More
How biosimilar priced in US market?
Unlike generics, biosimilars are not highly discounted to it’s patented molecule. Biosimilars are in average around 15-20% lesser price tag (considering WAC*)... Read More
Pfizer launched Zirabev, Ruxience, Trazimera biosimilar in US
Posted on29 Jan 2020
TagsBevacizumab, Biosimilar, MAB, monoclonal antibody, pfizer, Rituximab, Ruxience, trastuzumab, Trazimera, Zirabev
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Pfizer has launched three biosimilars in the U.S. market. Pfizer has priced these biosimilars aggressively to get quick market share. Zirabev Biosimilar... Read More
What is USFDA Purple Book? What it’s significance?
Posted on19 Nov 2019
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The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act... Read More
USFDA approved Pfizer’s Abrilada, a biosimilar of Humira
Posted on19 Nov 2019
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The U.S. Food and Drug Administration (FDA) approved Pfizer’s Abrilada, a biosimilar of Humira. Pfizer said the FDA approved Abrilada (adalimumab-afzb) for the treatment of... Read More
Biocon, Mylan launch first insulin glargine biosimilar, Semglee in Australia
Biocon Ltd and Mylan N.V. announced the launch of Semglee (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen),... Read More
USFDA approval of Rituxan, in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older
Roche announced that the US Food and Drug Administration (FDA) has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of... Read More
Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)
U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment... Read More
List of USFDA approved Biosimilar [till date]
Click here to view the list.